NCT02387450

Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication

Reduction de la Morbi-mortalité Cardiovasculaire Chez l'artériopathe Claudicant Par le Sildenafil

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 30 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Sildenafil has shown potential effects both on vasodilator mechanisms and as an inhibitor of the NO/GMPc Pain activation. The investigators aim at estimating the benefit of sildenafil in term of morbi-mortality in patients with arterial claudication on a multicenter prospective double blind study.

Detailed description

Eligible patients will ask to participate after oral and written information. Evaluation of walking capacity (self reported and treadmill measured), co-morbid condition and quality of life (WELCH, SF-36, Edinburg) will be performed at inclusion, after the first dose and at 3 months of oral treatment through sildenafil 100mg/day or placebo from inclusion to 3 months. Indication for revascularisation will be evaluated at 3 months according to symptoms and walking capacity according to the Rutherford classification. Primary endpoint is the proportion of patients showing either a fatal events (cardio-vascular or noncardiovascular) or hospitalisation for non fatal cardiovascular events at 6 and 9 months follow up from inclusion.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DRUG	Sildenafil	100 mg per day
DRUG	Placebo	Placebo with same presentation as the active drug

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-06-01
• Completion: 2017-09-01
• First posted: 2015-03-13
• Last updated: 2015-03-13

Locations

1 site across 1 country: France